What happens when the contract manufacturer a device establishment selects for manufacturing support runs afoul of FDA?
In order to compete globally, companies must be proactive in their business plans and anticipate the challenges they may face, concur three med-tech executives.
Follow these eleven tips when outsourcing to your vendors. They will save you heartache, frustration, and money.
A high degree of risk identification and management throughout the supply chain is what establishes a company as ‘world class,’ says Steve C de Baca – Senior VP, Global Quality & Regulatory, Beckman Coulter Diagnostics.
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
Compliance to FDA’s requirements for distribution are well-scripted and relatively easy for device manufactures to comprehend. However, it is inevitable that Mr. Murphy will eventually visit a device manufacture, resulting in Dr. D’s favorite six-letter word – RECALL.
Material management is one of the most basic functions needed to successful manufacture finished medical devices. If adequate controls are not maintained over raw materials and appropriate identification and traceability maintained, then there will probably be a FDA Form 483 observation in your organization’s future.
If a medical device establishment is manufacturing sterile medical devices, make sure that environmental monitoring and the calibration and servicing of environmental control systems are part of the product realization equation.
As corporations look for diverse expertise and variable costs through outsourcing as well as looking to bring more through the pipeline with ever tighter resources, the challenges to managing the outsourced partners also increase.
If you are a returning visitor, welcome back to this 4th installment of Devine Guidance. If this is your first time, I hope you have a chance to read the first-three installments of my blog. In this installment, I will continue with the defensive-receiving inspection theme, a process that I feel “has limited-value.” That said,…